The Efficacy of Dynamic Hand Splint Treatment in Spastic Hemiparetic Patients

Chang Gung Medical Foundation

Status: Completed

Conditions: Brain Injuries; Stroke

Treatments: Behavioral: Task-oriented training with a dynamic hand splint; Behavioral: Task-oriented training without a dynamic hand splint

Study type: Interventional

Funder types: Other

Identifiers

NCT04441437

104-9569A3

Details and patient eligibility

About

The purpose of this randomized controlled trial was designed to study the efficacy of dynamic hand splinting on spastic hemiparetic patients due to stroke or traumatic brain injury.

Full description

Subjects were recruited from both inpatients and outpatients who received rehabilitation programs in the Department of Physical Medicine and Rehabilitation at a regional teaching hospital in Taiwan. The participants were randomly divided into two groups: the splint group and the control group. The subjects in the splint group received 1-hour task-oriented training with wearing a customized dynamic hand splint, totally 15 times in a duration of one month plus conventional rehabilitation programs. The subjects in the control group received the same treatments but without splint used. Evaluations including Modified Ashworth Scale (MAS), active range of motion (AROM), grip strength, Fugl-Meyer Assessment (FMA), Motor Activity Log 30(MAL), and F/M ratio were performed at baseline, post-training, and 2 months later after the intervention finished, and the evaluators were blinded to the grouping of the subjects.

Enrollment: 35 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• an age of 20 to 85 years
• the duration of stroke or brain injury more than 6 months
• unilateral hemiparesis with intact sound side limbs function
• the Brunnstrom's stage of both arm and hand ≥ III
• able to follow instructions, wear a dynamic hand splint and perform therapeutic activities
• wrist spasticity with a Modified Ashworth Scale score 1-3
• willing to provide the written informed consent.

Exclusion criteria

• patients with apraxia
• cognitive impairment with a Mini-Mental State Examination (MMSE) score < 25
• any fixed contracture of the affected wrist or fingers
• a history of peripheral nerve injury, other severe neuromuscular disease or musculoskeletal deformity change in the affected side upper extremity
• a history of alcohol or phenol injection to the affected side upper extremity
• Botulinum toxin injection to the affected side upper extremity for the treatment of spasticity within 4 months before the study
• surgical treatment for spasticity to the affected side upper extremity
• active infection
• obvious atrophy of muscles in the affected side upper extremity
• bilateral upper extremities weakness
• any dermatosis or open wounds in the affected upper extremity or an allergy to the splint.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

35 participants in 2 patient groups, including a placebo group

Splint Group

Experimental group

Description:

1-hour task-oriented training with wearing a customized dynamic hand splint, totally 15 times in a duration of one month.

Treatment:

Behavioral: Task-oriented training with a dynamic hand splint

No-Splint Group

Placebo Comparator group

Description:

1-hour task-oriented training without wearing a customized dynamic hand splint, totally 15 times in a duration of one month.

Treatment:

Behavioral: Task-oriented training without a dynamic hand splint